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FDA 510(k)

IM COLLAGEN SHIELD

K-Number: K896449 · 1990-05-24

ApplicantIntermedical, Inc.
Decision Date1990-05-24
Product CodeMOE
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

IM COLLAGEN SHIELD is the device name listed in this FDA 510(k) record. The listed applicant is Intermedical, Inc.. It received FDA 510(k) clearance on 1990-05-24 under 510(k) number K896449. The device is classified under product code MOE. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IM COLLAGEN SHIELD?

IM COLLAGEN SHIELD is a medical device that received FDA 510(k) clearance on 1990-05-24. The listed applicant is Intermedical, Inc.. The 510(k) number is K896449.

When did IM COLLAGEN SHIELD receive FDA 510(k) clearance?

IM COLLAGEN SHIELD received FDA 510(k) clearance on 1990-05-24, under 510(k) number K896449.

Who is the listed applicant for IM COLLAGEN SHIELD?

The FDA 510(k) record lists Intermedical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IM COLLAGEN SHIELD?

The FDA product code for IM COLLAGEN SHIELD is MOE.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: MOE)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K944872BIO-COR COLLAGEN CORNEAL SHIELDBausch & Lomb Healthcare and Optics WorldwideK915861MEDILENS-CS CORNEAL SHIELDChiron OphthalmicsK914529SOFTSHIELD(TM) 12, 24, 72 COLLAGEN CORNEAL SHIELDSOasis Medical, Inc.K913148COLLAGEN SHIELD FOR ACUTE CAREVitaphore Corp.K905825COLLAGEN SHIELD, VARIOUS MODELSChiron OphthalmicsK902558COLLAGEN SHIELD FOR ACUTE CAREVitaphore Corp.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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